Guidance on Risk Management Tools (September 2016)

HCP and Patient Targeted Risk Minimization Tools (RMTs)

Background:

PAAB has received several questions and submissions for HCP and patient targeted Risk Minimization Tools (RMTs). The present document is intended to guide industry in creation of compliant RMTs. Although the principles discussed in this guidance have been reviewed by Health Canada, this document may be superseded by future Health Canada guidance.

Note that the terms risk minimization tool, and risk management tool are often used interchangeably.

Risk Management Tools are documents which are part of a Health Canada mandated or Global mandated risk management plan or program. This means that some RMTs are mandated and approved by Health Canada while others are Global initiatives (which are not reviewed by Health Canada). The latter is more common than the former.

The purpose of RMTs is to convey important identified risks, important potential risks, and missing information about a manufacturer’s products. They do not contain claims of benefit as these tools are created solely with the aim of minimizing / managing / mitigating risk. Although distribution of such tools need not be in response to unsolicited requests, they are NOT intended or destined for promotional activities/uses and may not be used in such ways unless they undergo standard PAAB approval.

The PAAB encourages the sponsors to keep Health Canada aware of involvement in risk minimization activities.

How does PAAB approach RMT assessment?

Consider the following factors:

 

Guidance for PAAB Opinion Submissions Relating to RMTs (i.e. “yes” is the response to at least one question in figure 1)

 

  • As these risk management tools are not created with the intent to promote products, PAAB’s role is to ensure that the materials are non-promotional or to inform manufacturers of the revisions required to render the tool non-promotional (such that it does not directly or indirectly contravene the legislative and regulatory advertising provisions of the Food and Drugs Act and Regulations).
  • PAAB’s review takes the form of a written opinion based on direction from Health Canada and consideration of the general principles in the Health Canada policy document “The Distinction Between Advertising and Other Activities”. See the fee schedule on the PAAB website for costs relating to the opinion service.

Specific Guidance for PAAB Opinion Submissions Relating to RMTs

Manufacturer letter 

A letter from the manufacturer confirming that Health Canada approved the RMT.   

  • Note that even when Health Canada has approved risk management plans, the contents of RMTs have been reviewed from a pharmacovigilance, clinical and/or scientific perspective rather than a regulatory advertising one.  Health Canada therefore recommends that sponsors use the PAAB preclearance review mechanism for all risk minimization / mitigation / management tools to help manufacturers comply with the legislative and regulatory advertising provisions of the Food and Drugs Act and Regulations even if the tool is approved by Health Canada.
  • Risk management tools undergoing review by a government authority should only be submitted to PAAB after completion of that review (i.e. the PAAB assessment must be on the final version of the tool).

OR (when not approved by Health Canada)

A signed letter from the manufacturer’s medical department (or equivalent) confirming that the entire tool has been internally reviewed and approved for scientific accuracy and consistency with the product monograph.   

Tonality

The tone must be one of caution throughout the document. The purpose of any message within such piece is to minimize, manage, and inform about risk. Appropriate dosing, for example, is one way to manage risk.

Statements  of benefit

There may be no direct or implied content about product benefits (even if scientifically accurate) and no product claims (whether comparative or non-comparative).

See additional considerations for HCP targeted tools below. 

Product Branding Elements

Generally, the product logo and colour scheme may be employed for RMTs pertaining to the corresponding particular product. This is not a requirement. See exception below relating to off-label content.

Off-label

Only uses authorized in Canada should be discussed unless distribution of the tool will be limited to unsolicited requests. PAAB will consult with Health Canada if discussion of off-label use is critical to appropriate risk management. 

Title

The document name should not imply that Health Canada has approved the document. In the past, Health Canada requested that the term “Safety monograph” not be used. The combination of ‘Safety’ with ‘monograph’ may suggest that Health Canada has provided full approval of the tool.

Disclaimer

The first surface (e.g. exterior front cover) must carry a statement along the lines of “This material was developed by [manufacturer name], as part of the risk minimization plan for [product name]. This material is not intended for promotional use”. If this is not a product tool, the segment ‘for [product name]’ must not be used.

PAAB logo

The PAAB opinion assessment is generally limited to confirming that the tool is non-promotional and that the criteria in this document are met (e.g. the content was not assessed by PAAB for scientific/clinical accuracy). The tool, therefore, should not contain the PAAB logo.

References

Given the nature of the PAAB assessment described above, references need not be included in the submission. Exception: The relevant regulatory references such as the most recent product monograph and NOC letter are required.  

Modifications

It is important for manufacturers to update risk management tools as new information becomes available. Modified RMTs should be resubmitted to the PAAB for assessment. 

Renewals

Although a no objection letter will be provided upon completion of the review, it will not include an expiration date. Renewals are therefore not required for RMTs. See “modifications” in the section above.   

Context of use

Although RMTs can be promoted and distributed by representatives, they must not be used as detailing aids during a sales call unless full review and approval from PAAB is obtained (i.e. rather than an opinion submission).  On-label product branded RMTs can  be distributed with product branded APS (see  provisions below relating to off-label content below).

If the tool contains any off-label content (only after consultation with Health Canada), there may be no:

  • use of the product logo or product branding colours
  • distribution in promotional contexts (e.g. sales reps)
  • distribution or housing alongside product branded (and/or promotional) materials
  • mention of the tool in branded and/or promotional materials

Considerations specific to the target audience for PAAB Opinion Submissions Relating to RMTs

Patient

Tools intended for patients should be comprised of non-promotional discussion of risks and mitigation strategies that are relevant to a patient on that particular drug. i.e. documented or potential risks for the  prescribed drug and/or that product’s class in general. Other prescription healthcare products/classes may not be mentioned. It is acceptable to use language along the lines of “As a risk of X has been observed for some products used in the treatment of this condition, you should keep an eye out for X and inform your doctor if it occurs”.

EXCEPTION relating to mention of other specific products: other prescription healthcare products can be discussed to the extent that they are discussed in part III of the prescribed drug’s product monograph and/or its indication. Additionally, if the tool is intended to be distributed specifically to patients taking two products concomitantly, this should be conveyed prominently on the tool’s front cover, along with identifying the specific products.

HCP

Tools intended for HCPs should be comprised of non-promotional discussion of risks and mitigation strategies relating to the sponsor’s product/class OR risk messages relating to other products framed as potential risks of the sponsor’s product.  Presentations conveying that the manufacturer’s product does not have a particular risk (or poses less risk than other products/classes/categories) are not acceptable. 

Manufacturers should exercise caution when summarizing study results as this has the potential to provide an incomplete (and therefore inaccurate) picture of the available evidence and may introduce bias, which could render the material subject to all advertising regulations. The sponsor’s medical department must ensure the presentation does not omit important data relevant to the sponsor product’s risk. 

FAQ:

  1. What if the manufacturer plans to:
    • Instruct/train drug representative to detail from the RMT during a sales call in order to make sure HCPs consume this important content?
    • Include product claims and statements of benefits in order to establish balance in the tool?

    The piece would simply be subject to all PAAB code provisions relating to APS and to standard review times.

  2. Can PAAB approved APS mention on-label RMTs?

    Yes. Product branded APS can mention on-label product branded RMTs. (see provisions below relating to off-label content above).

  3. Can on-label RMTs appear on websites along with with PAAB approved APS (e.g. on a gated website).

    Yes. Product branded APS need not be stored in separate silos  from on-label product branded RMTs . The manufacturer should ensure to clearly distinguish between RMTs and PAAB approved APS (i.e. PAAB approved APS contain the PAAB logo while RMTs contain the disclaimer discussed above) . 

  4. Will PAAB provide an approval number and approval period?

    As no PAAB logo should appear on the piece, no approval number or approval period will be provided. This means there is no need to renew the piece annually.

    The final PAAB letter will read “The PAAB has no objection to the attached piece. This piece does not require renewal. Note that future modifications made to the piece should be resubmitted to the PAAB for assessment.”

  5. What are the timelines for this assessment?

    The standard timelines for an opinion (4 business days for first response, 3 business days for revisions).

  6. What are the review fees?

    Same fee structure as APS on our fee schedule: http://www.paab.ca/fee-schedule-services.htm

code.paab.ca/resources/Guidance_on_Risk_Managment_Tools_(September_2016typo_fixed)_(1).pdf

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